(1) Field of the Invention
The invention relates to methods and devices for measuring, analyzing, and displaying a woman's daily fertility status.
(2) Description of Related Art (Including Information Disclosed Under 37 CFR 1.97 and 1.98)
Measuring the “Basal Body Temperature” (“BBT”) is a known method of fertility calculation. However, in the past a woman had to put the self-measured data on a graph each time that she took her temperature; the calculation and analysis were done manually by her. This is time consuming; human error can not be excluded. Other natural family planning devices exist. Existing devices such as fertility monitors and ovulation predictors use indications such as BBT, saliva, mucous analysis, or the measurement of hormonal changes in salvia or urine to depict ovulation.
Many monitoring methods have been patented, based on a wide variety of physical or chemical bodily changes believed to be indicative of the progress of the ovulation cycle. The following patents and patent applications are examples of such methods.
U.S. Pat. No. 3,749,089 describes an instrument for monitoring ovulation including a dual electrode vaginal probe and monitoring device, for indicating the magnitude and polarity of the electrochemical response of vaginal fluids.
U.S. Pat. No. 3,924,609 describes a test procedure and apparatus for determining low DC potentials for measurement and identification of the different phases as well as the fact of ovulation in adult mammalian females.
U.S. Pat. No. 3,926,037, U.S. Pat. No. 3,928,423, U.S. Pat. No. 4,002,056, U.S. Pat. No. 4,013,066 and U.S. Pat. No. 4,059,986, describe devices for determining the properties (particularly surface tension) of bodily mucus as an indication of menstrual cycle phase.
U.S. Pat. No. 3,986,494 and U.S. Pat. No. 4,010,738 describe a method of monitoring the concentration of volatile organic compounds having a molecular weight of between 50 and 350, found in vaginal secretions.
U.S. Pat. No. 4,031,365 describes a system for continuously monitoring and displaying temperature to indicate ovulation activity.
U.S. Pat. No. 4,036,212 describes a method of monitoring the progress of the ovulation cycle which comprises periodically determining the concentration of ATP in vaginal fluid.
U.S. Pat. No. 4,119,089 describes a method for predicting and ascertaining the time of ovulation by monitoring the level of at least one volatile sulphur compound commonly occurring in mouth air.
U.S. Pat. No. 4,148,304 describes a system for determining the time of ovulation in females including an ear probe which measures body temperature and a probe which measures body potential together with an electronic amplification circuit and indicating device which is capable of measuring small changes in temperature and body potential and providing a portable and, convenient device for determining time of ovulation.
U.S. Pat. No. 4,151,831 describes a fertility indicator for measuring and detecting the body temperature of a human subject over a menstrual cycle, having a timer for generating time based signals, and a logic circuit connected to the clock timer and being responsible to the time based signals for selecting the proper combinations of the time based signals and for indicating the correct present time. There are various types of temperature sensors (vaginal probe, mouth probe, or waist belt) that can be used, coupled to a logic circuit for measuring the body temperature of the human subject. A solid state memory circuit having coded information command signals is coupled to the logic circuit for sequencing the logic circuit to take a plurality of temperature readings at a preset real time and to terminate the readings when the temperature has stabilized. A data storage circuit is provided for sequentially recording each of the stabilized temperatures that were measured, and a display circuit responsive to the solid state memory and data storage circuits, indicates the status of fertility of the subject during a menstrual cycle. There is also an alarm circuit coupled to, the logic circuit and it has a variable pitch responsive to the solid state memory circuit for indicating the time when the subject's temperature has to be taken. Lights or words can indicate the user's status.
U.S. Pat. No. 4,151,833 describes a method for detecting ovulation by measuring the water content of the cervical mucus using a pellet made from a water-swellable polymer.
U.S. Pat. No. 4,246,907 describes a method for predicting ovulation based on measuring every day throughout at least a substantial portion of the days of the menstrual cycle, the polarity of a direct current potential between at least two spaced apart portions of a woman's body.
U.S. Pat. No. 4,465,077 describes a fertility computer having the ability to store information about a user's past menstrual cycle history, basal body temperature, and gynaecological disorders which; along with certain prediction indicators, is used to predict statistically when ovulation will occur. The information is processed in accordance with a pre-determined program which ascribes certain values to the parameters to predict the present fertility status of the user.
U.S. Pat. No. 5,657,762 describes a method of monitoring the ovulation cycle of a female mammal, involving regular measurement of basal body temperature throughout a current ovulation cycle and occasional measurement of the level of at least one urinary component of significance in the cycle, the measurement of the urinary component being conducted at predetermined stages in the cycle to check that the level is consistent with a predicted level and thus confirm that the cycle as a whole is consistent with a prediction.
U.S. Pat. No. 6,110,125 describes an indicating device for menstruation that includes: an ear-temperature measuring sensor to measure basal body temperatures of a user and output the measured values; a parameter-inputting means for inputting user-inputting parameters; a microprocessor for storing the basal body temperatures from the temperature measuring sensor, and storing the user-inputting parameters from the parameter inputting means, then using a mathematical method to estimate the user's monthly gynecophysiological factors in accordance, with the basal body temperatures and the user-inputting parameters; and a display means to display the user's monthly gynecophysiological factors estimated by the microprocessor. The indicating device for menstruation uses a mathematical method including weighting coefficients to estimate a user's monthly gynecophysiological factors more accurately.
U.S. Pat. No. 6,861,079 describes a basal body temperature thermometer and a chart with instructions to confirm when and if ovulation will/did occur. Commercially available urinary chemical reagent strips are provided with instructions so as to predict/confirm if and when ovulation will occur.
U.S. Pat. Application No. 20040081024 describes a wristwatch for taking the basal body temperature of a female and predicting her ovulation phase. The wristwatch has all of the following inside its case: a control circuit; a display; a memory; a timer; a battery; a wrist-temperature sensor, and a computer.
U.S. Pat. Application No. 20070191729 describes a basal body temperature (“BBT”) measurement method which includes: measuring each distance to at least one ear canal area by emitting a pulse to a user's ear canal; measuring a body temperature in the ear canal area utilizing infrared rays; recognizing a first body temperature, corresponding to a first distance which satisfies a predetermined standard, as the user's eardrum temperature; and converting the eardrum temperature into the user's BBT.
A device that separates the thermometer from data entry, data analysis, data storage, and data display, is currently sold in the United States by Valley Electronics LLC, in Eden, Md., (web page is http://www.lady-comp.com/en/) as the “Lady-Comp” device, which connects a temperature probe via an extendible, flexible cord to a hand-held device that accepts the temperature measurement, compares it with past temperature measurements, analyzes all the data, determines fertility status, and then displays that status. However, the thermometer must stay connected via its cord to the hand-held device, while measuring the woman's temperature.
None of the systems described above uses a personal electronic device as a user interface in combination with an intelligent thermometer, which does all the calculations needed for the analysis of the female cycle, and which also displays the woman's fertility status. The only known existing systems using both a personal electronic device and an intelligent thermometer are of two types: first, a thermometer without cycle analysis combined with analysis application on the personal electronic device; and second, an intelligent preprogrammed thermometer with cycle analysis and readout capability. End user interaction (settings, editing menstruation recordings, etc.) is not intended to be done with the personal electronic device. The first type has the disadvantage that the temperature values have to be transferred manually to the personal electronic device, thus giving rise to possible mistakes, and is uncomfortable. The second type lacks the possibility to enter user information (Such as menstruation data) directly into the personal electronic device in a way that the consistency of data with the intelligent preprogrammed thermometer is assured.
In light of the foregoing, a need remains for a system and method to allow the appraisal of a woman's menstrual cycle (i.e. corpus luteum insufficiency, anovulation, ovulation) through the use of a small oral thermometer which can analyze, store, and display fertility status, and then also communicate with a woman's personal electronic device, or personal digital assistant, such as a Blackberry, an iPod or some other such “smart” phone to store and display the fertility status.